Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR) (NCT NCT05066230)
NCT ID: NCT05066230
Last Updated: 2024-09-05
Results Overview
Percentage of patients improving ≥2 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
253 participants
Primary outcome timeframe
Day 1 to Week 48
Results posted on
2024-09-05
Participant Flow
Participants were recruited based on physician referral at 52 medical centers between September 2021 and August 2022. The first participant was enrolled on 07 September 2021 and the last on 25 August 2022.
Of 560 screened participants, 253 met eligibility criteria and were randomized to treatment.
Participant milestones
| Measure |
KSI-301 - Treatment Group A
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
Treatment Group B
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
|---|---|---|
|
Primary Study (Through Week 48)
STARTED
|
128
|
125
|
|
Primary Study (Through Week 48)
COMPLETED
|
120
|
115
|
|
Primary Study (Through Week 48)
NOT COMPLETED
|
8
|
10
|
|
After Week 48
STARTED
|
120
|
115
|
|
After Week 48
COMPLETED
|
0
|
0
|
|
After Week 48
NOT COMPLETED
|
120
|
115
|
Reasons for withdrawal
| Measure |
KSI-301 - Treatment Group A
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
Treatment Group B
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
|---|---|---|
|
Primary Study (Through Week 48)
Adverse Event
|
1
|
4
|
|
Primary Study (Through Week 48)
Non-compliance with study schedule
|
0
|
1
|
|
Primary Study (Through Week 48)
Withdrawal by Subject
|
4
|
2
|
|
Primary Study (Through Week 48)
Lost to Follow-up
|
2
|
3
|
|
Primary Study (Through Week 48)
Participant relocated
|
1
|
0
|
|
After Week 48
Adverse Event
|
1
|
0
|
|
After Week 48
Non-compliance with study schedule
|
1
|
0
|
|
After Week 48
Withdrawal by Subject
|
0
|
1
|
|
After Week 48
Lost to Follow-up
|
3
|
3
|
|
After Week 48
Sponsor Request
|
115
|
111
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
Baseline characteristics by cohort
| Measure |
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
57 years
STANDARD_DEVIATION 9.63 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
108 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Geographic Region
North America
|
123 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Geographic Region
Rest of World
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Diabetic Retinopathy Severity Scale (DRSS) at Baseline
DRSS Level ≤47
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Diabetic Retinopathy Severity Scale (DRSS) at Baseline
DRSS Level ≥53
|
82 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Percentage of patients improving ≥2 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Percentage of Patients Improving ≥2 Steps on DRSS
|
2 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Percentage of patients developing any of the following Sight-Threatening Complication: Proliferative Diabetic Retinopathy (PDR), Anterior segment neovascularization (ASNV), Vitreous hemorrhage or tractional retinal detachment believed to be due to PDR, or Diabetic Macular Edema (DME) from baseline through Week 48
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Percentage of Patients Developing Any Sight-Threatening Complication
|
26 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Percentage of patients improving ≥3 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Percentage of Patients Improving ≥3 Steps on DRSS
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Percentage of patients developing Proliferative Diabetic Retinopathy (PDR) from baseline through Week 48
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Percentage of Patients Developing PDR
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Percentage of patients developing Proliferative Diabetic Retinopathy (PDR) or Anterior segment neovascularization (ASNV) from baseline through Week 48
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Percentage of Patients Developing PDR or ASNV
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Percentage of patients developing vitreous hemorrhage or tractional retinal detachment believed to be due to Proliferative Diabetic Retinopathy (PDR) from baseline through Week 48
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Percentage of Patients Developing Vitreous Hemorrhage or Tractional Retinal Detachment Believed to be Due to PDR
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Percentage of patients developing Diabetic Macular Edema (DME) from baseline through Week 48
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Percentage of Patients Developing DME
|
17 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Percentage of patients with a ≥2-step or ≥3-step worsening on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Percentage of Patients With a ≥2-step or ≥3-step Worsening on DRSS
Patients with a ≥2-step worsening on DRSS
|
5 Participants
|
1 Participants
|
|
Percentage of Patients With a ≥2-step or ≥3-step Worsening on DRSS
Patients with a ≥3-step worsening on DRSS
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment. The Overall Number of Participants Analyzed were 128 and 125, but the number analyzed for each row is different depending on the number of participants with data for that row.
Percentage of patients who lost ≥5, ≥10, or ≥15 letters in Best-corrected Visual Acuity (BCVA) from baseline by visit over time. Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 5 letters from baseline to Week 8
|
15 Participants
|
8 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 5 letters from baseline to Week 20
|
15 Participants
|
15 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 5 letters from baseline to Week 32
|
10 Participants
|
17 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 5 letters from baseline to Week 44
|
8 Participants
|
12 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 5 letters from baseline to Week 48
|
11 Participants
|
14 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 10 letters from baseline to Week 8
|
3 Participants
|
2 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 10 letters from baseline to Week 20
|
4 Participants
|
2 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 10 letters from baseline to Week 32
|
1 Participants
|
5 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 10 letters from baseline to Week 44
|
2 Participants
|
4 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 10 letters from baseline to Week 48
|
1 Participants
|
5 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 15 letters from baseline to Week 8
|
1 Participants
|
1 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 15 letters from baseline to Week 20
|
1 Participants
|
1 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 15 letters from baseline to Week 32
|
0 Participants
|
4 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 15 letters from baseline to Week 44
|
0 Participants
|
0 Participants
|
|
Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
Participants who lost ≥ 15 letters from baseline to Week 48
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment. Subjects who did not have an event were censored at the date of the last scheduled study visit at or prior to Week 48.
Time to first development of Proliferative Diabetic Retinopathy (PDR), Anterior segment neovascularization (ASNV), or Diabetic Macular Edema (DME) through Week 48
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Time to First Development of PDR, ASNV, or DME
|
NA Months
Interval 11.5 to
NA = Not available due to small number of PDR, ASNV, and DME events
|
NA Months
NA = Not available due to small number of PDR, ASNV, and DME events
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment. Subjects who did not have an event were censored at the date of the last scheduled study visit at or prior to Week 48.
Time to first development of Proliferative Diabetic Retinopathy (PDR) or Anterior segment neovascularization (ASNV) through Week 48
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Time to First Development of PDR or ASNV
|
NA Months
Interval 11.5 to
NA = Not available due to small number of PDR and ASNV events
|
NA Months
NA = Not available due to small number of PDR and ASNV events
|
SECONDARY outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment. Subjects who did not have an event were censored at the date of the last scheduled study visit at or prior to Week 48.
Time to first development of vitreous hemorrhage or tractional retinal detachment believed to be due to Proliferative Diabetic Retinopathy (PDR) through Week 48
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Time to First Development of Vitreous Hemorrhage or Tractional Retinal Detachment Believed to be Due to PDR
|
NA Months
NA = Not available due to small number of vitreous hemorrhage and tractional retinal detachment events
|
NA Months
NA = Not available due to small number of vitreous hemorrhage and tractional retinal detachment events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment. Subjects who did not have an event were censored at the date of the last scheduled study visit at or prior to Week 48.
Time to first development of Diabetic Macular Edema (DME) through Week 48
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Time to First Development of DME
|
NA Months
NA = Not available due to small number of DME events
|
NA Months
NA = Not available due to small number of DME events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Mean change in Optical Coherence Tomography (OCT) central subfield retinal thickness (CST) from baseline by visit over time
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Mean Change in OCT CST
Week 8
|
4.5 Microns
Standard Deviation 17.22
|
-9.8 Microns
Standard Deviation 10.64
|
|
Mean Change in OCT CST
Week 20
|
6.6 Microns
Standard Deviation 28.99
|
-12.8 Microns
Standard Deviation 13.42
|
|
Mean Change in OCT CST
Week 32
|
5.2 Microns
Standard Deviation 27.86
|
-13.9 Microns
Standard Deviation 14.88
|
|
Mean Change in OCT CST
Week 44
|
-0.5 Microns
Standard Deviation 17.12
|
-8.9 Microns
Standard Deviation 19.71
|
|
Mean Change in OCT CST
Week 48
|
-0.7 Microns
Standard Deviation 15.76
|
-15.2 Microns
Standard Deviation 16.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Week 48Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment. The Overall Number of Participants Analyzed were 128 and 125, but the number analyzed for each row is different depending on the number of participants with data for that row.
Mean change in Best-corrected Visual Acuity (BCVA) from baseline by visit over time. Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Outcome measures
| Measure |
Treatment Group B
n=125 Participants
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A
n=128 Participants
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
|---|---|---|
|
Mean Change in BCVA
Week 8
|
0.2 ETDRS Letters
Standard Deviation 4.80
|
1.3 ETDRS Letters
Standard Deviation 5.02
|
|
Mean Change in BCVA
Week 20
|
0.3 ETDRS Letters
Standard Deviation 6.29
|
1.1 ETDRS Letters
Standard Deviation 5.22
|
|
Mean Change in BCVA
Week 32
|
1.2 ETDRS Letters
Standard Deviation 4.87
|
0.9 ETDRS Letters
Standard Deviation 8.68
|
|
Mean Change in BCVA
Week 44
|
1.6 ETDRS Letters
Standard Deviation 5.55
|
1.0 ETDRS Letters
Standard Deviation 5.63
|
|
Mean Change in BCVA
Week 48
|
1.5 ETDRS Letters
Standard Deviation 5.49
|
1.1 ETDRS Letters
Standard Deviation 6.44
|
Adverse Events
KSI-301 - Treatment Group A (Day 1 to Week 48)
Serious events: 18 serious events
Other events: 49 other events
Deaths: 1 deaths
Treatment Group B (Day 1 to Week 48)
Serious events: 12 serious events
Other events: 51 other events
Deaths: 1 deaths
KSI-301 - Treatment Group A (Post Week 48 to End of Study)
Serious events: 8 serious events
Other events: 15 other events
Deaths: 1 deaths
Treatment Group B (Post Week 48 to End of Study)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KSI-301 - Treatment Group A (Day 1 to Week 48)
n=128 participants at risk
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
Treatment Group B (Day 1 to Week 48)
n=125 participants at risk
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A (Post Week 48 to End of Study)
n=120 participants at risk
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
Treatment Group B (Post Week 48 to End of Study)
n=115 participants at risk
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
1.6%
2/128 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Cardiac disorders
Angina unstable
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Cardiac disorders
Atrioventricular block
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Cardiac disorders
Cardiac arrest
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Eye disorders
Retinal vein occlusion - Fellow Eye
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
General disorders
Chest pain
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
1.7%
2/120 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
General disorders
Impaired healing
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Localised infection
|
1.6%
2/128 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Osteomyelitis
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
1.6%
2/125 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
1.7%
2/120 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Cellulitis
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Complicated appendicitis
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Infected cyst
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Sepsis
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Septic shock
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Urinary tract infection
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.78%
1/128 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Nervous system disorders
Ischaemic stroke
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.87%
1/115 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Renal and urinary disorders
Renal failure
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.87%
1/115 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.78%
1/128 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.80%
1/125 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.87%
1/115 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/128 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/125 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/120 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.87%
1/115 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
Other adverse events
| Measure |
KSI-301 - Treatment Group A (Day 1 to Week 48)
n=128 participants at risk
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
Treatment Group B (Day 1 to Week 48)
n=125 participants at risk
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
KSI-301 - Treatment Group A (Post Week 48 to End of Study)
n=120 participants at risk
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301: Intravitreal injection
|
Treatment Group B (Post Week 48 to End of Study)
n=115 participants at risk
Sham injection on the same schedule as Treatment Group A
Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
|
|---|---|---|---|---|
|
Eye disorders
Cataract - Study Eye
|
10.2%
13/128 • Number of events 14 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
4.0%
5/125 • Number of events 5 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
2.5%
3/120 • Number of events 3 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Eye disorders
Conjunctival haemorrhage - Study Eye
|
7.0%
9/128 • Number of events 9 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
3.2%
4/125 • Number of events 5 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Eye disorders
Cataract - Fellow Eye
|
5.5%
7/128 • Number of events 7 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
2.4%
3/125 • Number of events 3 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Eye disorders
Diabetic retinal oedema - Study Eye
|
1.6%
2/128 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
14.4%
18/125 • Number of events 19 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
2.5%
3/120 • Number of events 3 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
2.6%
3/115 • Number of events 3 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Eye disorders
Diabetic retinopathy - Study Eye
|
1.6%
2/128 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
6.4%
8/125 • Number of events 8 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
2.6%
3/115 • Number of events 3 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Infections and infestations
COVID-19
|
7.0%
9/128 • Number of events 9 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
4.8%
6/125 • Number of events 7 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.83%
1/120 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.00%
0/115 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
11.7%
15/128 • Number of events 15 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
6.4%
8/125 • Number of events 8 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
2.5%
3/120 • Number of events 3 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
1.7%
2/115 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
|
Vascular disorders
Hypertension
|
9.4%
12/128 • Number of events 13 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
8.0%
10/125 • Number of events 10 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
1.7%
2/120 • Number of events 2 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
0.87%
1/115 • Number of events 1 • Adverse Events (AEs) reported through the End of Study or Early Termination (ET)
The "At Risk" numbers for "post Week 48 to the end of study" columns are number of participants who continued in the study after Week 48 from the Participant Flow.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60